NDA submission for the treatment of vulvovaginal candidiasis is expected in the second half of 2020.

Scynexis announced positive topline results from a second phase 3 study of ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC).

Ibrexafungerp is an investigational oral antifungal agent belonging to a novel class of structurally-distinct glucan synthase inhibitors known as triterpenoids. In the VANISH 306 trial, 188 patients with acute VVC were randomized to receive ibrexafungerp (300mg twice daily for 1 day) or placebo in a 2:1 ratio. The primary end point of the trial was clinical cure rate, defined as the complete resolution of all signs and symptoms at the Test-of-Cure (TOC) visit on day 10.

Results showed 63.3% of the ibrexafungerp-treated patients met the primary end point of clinical cure at the Day-10 TOC visit (P ≤.01), and 58.5% of ibrexafungerp-treated patients met the secondary end point of mycological eradication at the TOC visit (P ≤.001). Additionally, it was found that 73.9% of ibrexafungerp-treated patients had complete symptom resolution at the day 25 follow-up (P ≤.001).

Gastrointestinal side effects made up the majority of treatment-emergent adverse in patients treated with ibrexafungerp.The 3 most common GI events were diarrhea/loose stool, nausea and abdominal pain, which occurred in 9.4%, 8.4% and 2.7% of patients, respectively.